This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills. Responsibilities include EDC Entry and Query Resolution, developing strong working relationships and maintaining effective communication with study team members, building trust and respect between the clinic and the research office, assisting with screening, recruiting, and enrollment of research subjects, performing patient/research participant scheduling, collecting patient/research participant history, coordinating follow-up care and laboratory procedures, adhering to an IRB-approved protocol, assisting in the informed consent process of research subjects, supporting the safety of research subjects, coordinating protocol-related research procedures, study visits, and follow-up care, complying with company and Sponsor policies, SOPs, and guidelines, and scheduling subject visits and procedures. Qualifications include a High School Diploma and 1 year relevant work experience in clinical research, preferred experience in clinical research setting, working knowledge of clinical trials and Good Clinical Practices (GCP), in-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules, skill in carrying out required clinical procedures, working knowledge of medical terminology, attention to detail, ability to establish and maintain effective working relationships, and applicable certifications and licenses as required. This position is not eligible for sponsorship.
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